OEMs who want to be ‘first and fast’ in the medical device market need to expedite their design and development process while ensuring the absolute quality of their end products. Medical device prototyping is a key tool to achieve this, allowing you to test a device and problem-solve its glitches in a hands-on way as you iterate your designs. But who should you trust to help you develop your medical device prototype?
Medical devices are becoming more complex and powerful. They are supporting ground-breaking treatments and diagnostics through integrating electronics, IoT, and the latest bio-sensor tech.
But, as a result, the timescales for delivery are escalating and costs are spiralling while product cycles are getting faster.
Source: Digital Health Survey
OEMs developing medical devices often face serious obstacles around the speed and efficiency of their medical device development process.
Those with expertise in mechanical engineering can struggle to integrate required electronics and software, while those with electronics expertise can struggle with mechanical engineering. Both may need help with prototyping their devices to test their ideas and solve problems with their designs more quickly.
Add to this, the challenges of miniaturisation, ruggedisation, and quality assurance that building a medical device often entails - and the need for specialist medical device prototyping support becomes even more urgent.
Many OEMs will work with specialist design consultancies and access third-party medical device prototyping services at key stages of development to push their ideas forward.
And they’ll only transfer to a medical device manufacturer when prototypes have been tested and all designs finalised.
But in a world where speed is vitally important, this fragmentation of outsourced services makes little sense.
Without direct involvement with a manufacturer, there may be fundamental problems with production. You may end up with an inefficient manual assembly process, or dogged by component availability issues. You may be faced with delays as designs are reconfigured to fit the realities of the production line.
Working with an end-to-end EMS supplier, who can help prototype designs in an iterative way throughout your development process, will help you hit the ground running when you reach the medical device manufacturing stage.
Here’s why:
A specialist medical device prototyping firm may focus solely on design, but a manufacturing-focused EMS partner ensures that prototypes can be built with manufacturability and scalability in mind.
Design for Manufacturability (DFM) ensures that designs are optimised for medical device production, minimising the risk of rework and delays. Working with an end-to-end medical device manufacturer at this stage can anticipate all the problems that slow down the manufacturing process later on.
Medical devices must meet strict ISO 13485, FDA, and MDR requirements. A misstep in regulatory compliance can cause significant delays in clinical trials and product approval.
EMS providers with medical device manufacturing expertise have established risk management processes, traceability systems, and testing protocols to ensure compliance from the medical device prototyping phase onward.
EMS providers can give access to state-of-the-art medical device prototyping technologies that many OEMs lack, including:
EMS partners will have established relationships with component suppliers, allowing them to source high-quality parts at competitive prices. The right EMS will also have the in-house design and production capabilities (for example, PCBs and MOEMs) that will give you access to cutting-edge components without margin stacking. Supply chain ownership and expertise ensure that materials are procured efficiently, reducing lead times and cost overruns.
Medical devices must scale from prototype to production seamlessly. EMS providers are equipped to handle:
OEMs that work with specialist medical device prototyping firms often face delays when transitioning to mass production. EMS providers eliminate this risk by ensuring medical device prototype designs are production-ready from the outset.
Medical device manufacturing involves complex global supply chains. OEMs relying on in-house medical device prototyping may encounter:
An EMS provider proactively manages supply chain risks, ensuring a steady flow of components and materials for rapid prototyping and production.
Medical device prototyping is not a one-step process—it requires multiple iterations and refinements.
ESCATEC, for example, works hand-in-hand with OEMs to refine medical device prototypes through structured testing and validation cycles.
Through this iterative prototyping process, one of our clients proved its inhaler device across three prototype versions, incorporating size reduction, usability enhancements, and regulatory adjustments.
Visit our resources pages for more real-world medical device case studies including stories from Vibrosonic and Carl Reiner GmBH
The future of medical device prototyping is evolving. Having expertise in AI, advanced material science, and additive manufacturing (3D printing) is becoming integral to the prototyping process.
EMS providers are already investing in:
Over time, many companies have separated their design, prototyping, and manufacturing process across different outsourced suppliers. But there's been a heavy cost to this fragmentation - including inefficiencies in communication, higher costs, quality control challenges, and delayed time-to-market.
By partnering with an end-to-end EMS provider at the design and prototyping stage, OEMs can de-risk so much their medical device development process, identifying commerial and compliance issues early on - while remaining at the cutting edge of innovation.